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Chondroitin Sulfate for Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01245088
Recruitment Status : Withdrawn (Sponsor withdrew support after no patients enrolled)
First Posted : November 22, 2010
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Jeffry A. Katz, University Hospital Case Medical Center

Brief Summary:
Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: chondroitin sulfate Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
Study Start Date : January 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: chondroitin sulfate
400 mg (one table) TID
Drug: chondroitin sulfate
400 mg orally three times daily for 8 weeks



Primary Outcome Measures :
  1. Biologic effect on inflammation [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Colonic or ileocolonic CD diagnosed for at least 3 months. 2. Active CD, defined as a Crohn's Disease Activity Index (CDAI; Appendix A) [Best 1976] of greater than 200 but less than 320 at the time entry into the study.

    3. Age > 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment.

    5. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment.

    6. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment.

    7. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment.

    8. Patient on biologic therapy with infliximab, adalimumab, or certolizumab must be on stable therapy for 12 weeks prior to enrollment 9. Patient must sign informed consent.

Exclusion Criteria:

  • 1. Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement.

    2. Patients with known ulcerative colitis. 3. Patients expected to require surgery within 30 days for complications of CD. 4. Patients with CD and an intraabdominal abscess. 5. Patients requiring continuous antibiotics; antibiotics may be taken up to the point of enrollment into the study.

    6. Patients with severe cardiac, pulmonary, or renal disease. 7. Patients with a h/o malignancy other than resected basal cell carcinoma of the skin 8. Patients who have participated in another clinical research study in the past 8 weeks.

    9. Patients who are pregnant.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245088


Locations
United States, Ohio
University Hospitals Case medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center

Responsible Party: Jeffry A. Katz, Associate Professor of Medicine, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01245088     History of Changes
Other Study ID Numbers: CSCDZ
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

Keywords provided by Jeffry A. Katz, University Hospital Case Medical Center:
Crohn's disease
chondroitin sulfate

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases